American College of Physicians: Internal Medicine — Doctors for Adults ®

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ACP InternistWeekly



In the News for the Week of September 10, 2013




Highlights

Statins may reduce MI, stroke risk in elderly patients without established CVD

Statins may reduce risk of myocardial infarction (MI) and stroke in elderly patients without established cardiovascular disease (CVD), but they don't appear to affect short-term survival, according to a new meta-analysis. More...

Study suggests use of ultrasound criteria may reduce unnecessary thyroid biopsies

Certain characteristics of thyroid nodules, obtainable by ultrasound, could be used to predict the risk of thyroid cancer and reduce unnecessary biopsies, according to a recent study. More...


Test yourself

MKSAP Quiz: 6-month history of severe fatigue

A 47-year-old woman is evaluated for a 6-month history of severe fatigue in the afternoon that is often disabling. The patient has a 15-year history of multiple sclerosis. She describes no problems with her sleep, and her partner reports no unusual movements or apnea spells. In the morning, she feels well rested. Physical and neurologic examination findings, including vital signs, are normal. Following lab results, what is the most appropriate treatment of her fatigue? More...


Cardiology

Study of dabigatran with mechanical heart valves halted due to excess complications

Dabigatran caused more thromboembolic and bleeding complications than warfarin in patients with mechanical heart valves, according to a study that was prematurely halted as a result. More...


Anticoagulation

Oral anticoagulants and antiplatelets compared for risk of recurrent VTE, major bleeds

All oral anticoagulants and antiplatelet agents reduced recurrence of venous thromboembolism (VTE) compared with placebo, with aspirin reducing risk the least and vitamin K antagonists reducing it the most, a meta-analysis found. More...


Agency updates

Register now for successful PQRS participation

A new online registration tool, the Physician Value-Physician Quality Reporting System (PV-PQRS) Registration System, is available now for practices registering for the group practice reporting option (GPRO) for the PQRS and value-based payment (VBP) modifier programs. More...

CDC launches digital library

The Centers for Disease Control and Prevention recently launched CDC Stacks, a free digital library of scientific CDC publications. More...


From ACP Internist

The September issue of ACP Internist is online and coming to your mailbox

The September issue of ACP Internist is online and features stories about vaccine recommendations, dismissing patients and communicating with patients about cancer. More...


Cartoon caption contest

Put words in our mouth

ACP InternistWeekly wants readers to create captions for our new cartoon and help choose the winner. Pen the winning caption and win a $50 gift certificate good toward any ACP product, program or service. More...


Physician editor: Daisy Smith, MD, FACP



Highlights


.
Statins may reduce MI, stroke risk in elderly patients without established CVD

Statins may reduce risk of myocardial infarction (MI) and stroke in elderly patients without established cardiovascular disease (CVD), but they don't appear to affect short-term survival, according to a new meta-analysis.

Researchers analyzed eight trials to determine whether statins would benefit those without a history of CVD. Included trials randomly assigned patients to statins or placebo, reported outcomes in those who were at least 65 years of age at randomization and who did not have established CVD, and reported at least one of the following: all-cause death, cardiovascular death, MI, stroke or new onset of cancer. Relative risks were calculated for treatment effect and for each outcome by intention to treat, and overall estimates of effect were calculated with fixed-effects or random-effects models. The study results were published early online by the Journal of the American College of Cardiology.

The eight trials involved 24,674 elderly patients, 47% of whom were women, with a mean age of 73 years and a mean follow-up of 3.5 years. A total of 12,292 were assigned to statins and 12,382 were assigned to placebo. Overall, 2.7% of patients taking statins and 3.9% of those taking placebo had an MI during the follow-up period (relative risk, 0.606; P=0.003), while 2.1% and 2.8%, respectively, had a stroke (relative risk, 0.762; P=0.006). However, statins did not appear to reduce the risk for all-cause death (relative risk, 0.941; P=0.210) or cardiovascular death (relative risk, 0.907; P=0.493) compared with placebo, and new cancer onset did not appear to differ by treatment group (relative risk, 0.989; P=0.890).

The authors noted that their study was based on aggregate data, that only two of the included studies were designed for elderly patients, and that the follow-up was relatively short, among other limitations. However, they concluded that statins can reduce short-term incidence of MI and stroke in elderly patients without established CVD.

The current study, said an editorialist, "clearly answers the question of whether statins reduce events in primary prevention of individuals aged 65 or older." He pointed out that all of the patients included in the study had risk factors besides their age, including hypertension, diabetes, high low-density lipoprotein cholesterol level, low high-density lipoprotein cholesterol level, or a high level of C-reactive protein.

"Older people differ more among themselves than younger ones do, and the decision to treat or not treat an older individual with a statin often requires clinical discernment," the editorialist wrote. "The clear results of this meta-analysis will hopefully lead to more older individuals receiving treatment that will reduce their [cardiovascular] risk."


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Study suggests use of ultrasound criteria may reduce unnecessary thyroid biopsies

Certain characteristics of thyroid nodules, obtainable by ultrasound, could be used to predict the risk of thyroid cancer and reduce unnecessary biopsies, according to a recent study.

The retrospective case-control study included 8,806 patients who underwent 11,618 thyroid ultrasounds between 2000 and 2005. According to the California Cancer Registry, 105 of them were subsequently diagnosed with thyroid cancer. Researchers found three ultrasound nodule characteristics that predicted risk of thyroid cancer—microcalcifications (odds ratio [OR], 8.1; 95% CI, 3.8 to 17.3), size greater than 2 cm (OR, 3.6; 95% CI, 1.7 to 7.6) and an entirely solid composition (OR, 4.0; 95% CI, 1.7 to 9.2). Results were published online by JAMA Internal Medicine on Aug. 26.

The researchers calculated that if every nodule with any one of these characteristics was biopsied, the sensitivity would be 0.88 (95% CI, 0.80 to 0.94), but the false-positive rate would be high (0.44; 95% CI, 0.43 to 0.45) and the positive likelihood ratio would be low (2.0; 95% CI, 1.8 to 2.2), and one cancer would be found for every 56 biopsies. If two characteristics were required, sensitivity would be 0.52 (95% CI, 0.42 to 0.62), the false-positive rate would be 0.07 (95% CI, 0.07 to 0.08), the positive likelihood ratio would be 7.1 (95% CI, 6.2 to 8.2), and there would be one cancer found for every 16 biopsies.

The researchers calculated thyroid cancer risks at 2 per 1,000 for those with none of the characteristics, 18 per 1,000 for those with one, 62 per 1,000 with two characteristics and 960 per 1,000 with all three characteristics. Compared to some recommendations that currently call for biopsying all nodules over 5 mm, only biopsying those with two of the characteristics would reduce unnecessary biopsies by 90%, with only 5 per 1,000 unbiopsied patients having cancer, the study authors said. They called for a large prospective cohort study to validate these findings.

An accompanying commentary offered several critiques of the study, including that cancer prevalence was only 1.6% in the study population compared to other estimates of 8% to 15% of evaluated nodules. Current practice patterns shouldn't be altered by these findings, the editorialist said, and "nodules larger than 1.0 to 1.5 cm, especially those that are solid, are hypoechoic and contain microcalcifications should be sampled." The study was also accompanied by a perspective article about one physician's experience with thyroid cancer diagnosis and treatment.



Test yourself


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MKSAP Quiz: 6-month history of severe fatigue

A 47-year-old woman is evaluated for a 6-month history of severe fatigue in the afternoon that is often disabling. The patient has a 15-year history of multiple sclerosis. She states that her mood is good and that she is not feeling depressed or sad. She describes no problems with her sleep, and her partner reports no unusual movements or apnea spells. In the morning, she feels well rested. Medications are glatiramer acetate, low-dose baclofen, and a daily multivitamin.

mksap.gif

Physical and neurologic examination findings, including vital signs, are normal. Results of laboratory studies show a hemoglobin level of 12.9 g/dL (129 g/L), a normal mean corpuscular volume, and a serum thyroid-stimulating hormone level of 1.3 µU/mL (1.3 mU/L).

Which of the following is the most appropriate treatment of her fatigue?

A: Amantadine
B: Iron supplementation
C: Levothyroxine
D: Memantine
E: Substitution of an interferon beta for glatiramer acetate

Click here or scroll to the bottom of the page for the answer and critique.


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Cardiology


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Study of dabigatran with mechanical heart valves halted due to excess complications

Dabigatran caused more thromboembolic and bleeding complications than warfarin in patients with mechanical heart valves, according to a study that was prematurely halted as a result.

The phase II, manufacturer-sponsored study included patients who had undergone aortic- or mitral-valve replacement either within a week prior to drug initiation or more than three months earlier. They were randomly assigned to warfarin (adjusted to obtain an international normalized ratio of 2 to 3 or 2.5 to 3.5 depending on thromboembolic risk) or dabigatran (an initial dose of 150, 220 or 300 mg twice daily based on kidney function). Results were published online by the New England Journal of Medicine on Sept. 1.

The study was halted after enrollment of 252 patients, 162 of whom were treated with dabigatran. Fifty-two of those patients required adjustment or discontinuation of their dabigatran dose. More dabigatran patients than warfarin patients had ischemic or unspecified strokes (5% vs. zero) or major bleeding (4% vs. 2%, all pericardial bleeds). Study authors concluded that the drug showed no benefit and excess risk compared to warfarin.

They noted that most thromboembolic events occurred in the dabigatran group who started the drug within a week of surgery. The higher risk of thromboembolism might be due to inadequate plasma levels of the drug (although higher levels might have led to even more bleeding complications) or the difference in the two treatments' mechanisms of action (because dabigatran is less able to suppress coagulation resulting from exposure to artificial surfaces). The results show that dabigatran is not an acceptable alternative to warfarin for this indication and that the effectiveness of factor Xa inhibitors at preventing strokes in patients with atrial fibrillation should not be extrapolated to patients with mechanical valves, the authors concluded.

An accompanying editorial noted several aspects of the study that could explain the failure of dabigatran, including the timing of drug initiation and the lower-than-projected plasma levels of the drug. While agreeing that the use of dabigatran for this indication would place patients at undue risk, the editorialist added, "there is a palpable downside as well to potential premature abandonment of research into the use of such drugs in patients with mechanical heart valves."



Anticoagulation


.
Oral anticoagulants and antiplatelets compared for risk of recurrent VTE, major bleeds

All oral anticoagulants and antiplatelet agents reduced recurrence of venous thromboembolism (VTE) compared with placebo, with aspirin reducing risk the least and vitamin K antagonists reducing it the most, a meta-analysis found.

Researchers conducted a meta-analysis of 12 randomized, controlled studies from the published literature. Results were published online Aug. 30 by BMJ.

In the efficacy study population of 11,999 patients, all treatments reduced the risk of recurrent VTE. Vitamin K antagonists, given at a standard adjusted dose, defined as a target international normalized ratio of 2.0 to 3.0, showed the highest risk difference (odds ratio [OR], 0.07; 95% credible interval [CrI], 0.03 to 0.15) and aspirin showed the lowest risk difference (OR, 0.65; 95% CrI, 0.39 to 1.03) compared with placebo or observation groups.

Risk of major bleeding was higher with a standard adjusted dose of vitamin K antagonists (OR, 5.24; 95% CrI, 1.78 to 18.25) compared to placebo or observation groups. Also, among the 12,167 patients evaluated for safety, there was an increased risk of major bleeding associated with rivaroxaban and low-intensity vitamin K antagonists compared with placebo or observation.

Apixaban, 5 mg twice daily, had the highest probability (69%) of being the best treatment for reducing the risk of major bleeding events among all treatments. That regimen was associated with a reduction in major bleeding compared with standard adjusted-dose vitamin K antagonists, dabigatran, rivaroxaban (OR, 0.01; 95% CrI, 0.00001 to 0.4), and low-intensity vitamin K antagonists (OR, 0.04; 95% CrI, 0.0009 to 0.53).

After one trial was excluded, 16 (0.13%) of 12,090 patients had a fatal recurrent VTE; of these, nine had received placebo or observation. Five (0.04%) of 11,765 patients had a fatal bleeding episode; of these, four had received placebo or observation. There were no differences among treatments in fatal recurrent VTE or fatal bleeding events.

The researchers noted that risks for recurrent VTE and major bleeding are key pieces of information when doctors consider agents for secondary prevention. They wrote, "The rates of recurrent VTE and major bleeding events should be taken into account when assessing the efficacy and safety of different treatment strategies for secondary prevention for VTE. Other factors—including individual patient risk factors, case fatality, costs, lifestyle modifications, burden of laboratory monitoring, and patient values and preferences—should also be considered when making recommendations to patients regarding anticoagulant treatment."



Agency updates


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Register now for successful PQRS participation

A new online registration tool, the Physician Value-Physician Quality Reporting System (PV-PQRS) Registration System, is available now for practices registering for the group practice reporting option (GPRO) for the PQRS and value-based payment (VBP) modifier programs.

Using the new system, practices can select their reporting method for the PQRS program for calendar year 2013 and begin the process for avoiding the 1.5% PQRS penalty and the 1% VBP penalty in 2015.

To access the registration system, practices must have an Individual Authorized Access to the Centers for Medicare and Medicaid Services (CMS) Computer Services (IACS) account. For more information on the PV-PQRS and IACS account and to check whether your practice needs to register, visit the CMS website.

The PV-PQRS Registration System opened July 15 and will remain open until Oct. 15.

For more information on upcoming important dates related to a variety of regulatory, payment, educational and delivery system changes and requirements (including PQRS and VBP), visit ACP's Physician and Practice Timeline.


.
CDC launches digital library

The Centers for Disease Control and Prevention recently launched CDC Stacks, a free digital library of scientific CDC publications.

CDC Stacks includes peer-reviewed articles and CDC guidelines and recommendations. Users can search the full text of all documents and browse entries by public health subject. CDC Stacks is updated weekly.



From ACP Internist


.
The September issue of ACP Internist is online and coming to your mailbox

The September issue of ACP Internist is online and features stories including the following:

acpi-20130910-cover.jpg

Keep up with vaccine recommendations. New vaccines and recommendations have added complexity and made it tough to stay current. For patients, the extra costs can be prohibitive. Learn how to stay abreast of the requirements and engage patients on vaccination.

Dismissing patients always a last resort.Stopping the physician-patient relationship can be seen as abandonment if not done properly.

Communication skills vital to cancer conversations. Cancer patients want information, but not in a way that makes them lose hope. Effective shared decision making and risk communication strategies can help.

More stories, Test Yourself with the MKSAP Quiz and the latest blog posts of ACP members are online.



Cartoon caption contest


.
Put words in our mouth

ACP InternistWeekly wants readers to create captions for this cartoon and help choose the winner. Pen the winning caption and win a $50 gift certificate good toward any ACP product, program or service.

acpi-20130910-cartoon.jpg

E‑mail all entries to acpinternist@acponline.org. ACP staff will choose finalists and post them online for an online vote by readers. The winner will appear in an upcoming edition.


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MKSAP Answer and Critique



The correct answer is A: Amantadine. This item is available to MKSAP 16 subscribers as item 49 in the Neurology section. More information is available online.

This patient should be treated with amantadine. She is experiencing multiple sclerosis (MS)–related fatigue, a common but often overlooked symptom of the disorder. Fatigue is described as exhaustion that is unrelated to physical activity and may be exacerbated by hot weather. Exclusion of anemia, sleep disorders, depression, hypothyroidism, and other medical conditions is required to make a diagnosis of MS-related fatigue. Adequate rest, regular physical exercise, and treatment with stimulant drugs can be helpful. Currently, the most frequently prescribed treatments for this symptom are amantadine and modafinil. Amantadine also has antiviral and antiparkinsonian properties.

Although iron deficiency anemia should be part of the differential diagnosis when a patient with MS has fatigue, this patient does not show any evidence of anemia on laboratory testing.

Hypothyroidism is a reasonable consideration in a patient with MS who has fatigue, but this patient's serum thyroid-stimulating hormone level is in the normal range, which makes levothyroxine therapy unnecessary.

Memantine has been evaluated and found ineffective for improving MS-related cognitive deficits, which this patient does not have, and has no reported benefit in diminishing symptoms of fatigue in patients with the disorder.

Changing this patient's medication from glatiramer acetate to one of the interferon beta options is inappropriate because her fatigue is not an adverse effect of the glatiramer acetate. Her fatigue also does not constitute an MS relapse, which might necessitate a therapeutic switch.

Key Point

  • Amantadine and modafinil are used as symptomatic treatments of multiple sclerosis–related fatigue.

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Test yourself

A 30-year-old woman is evaluated for episodic migraine without aura that first presented in high school and has persisted into the third trimester of her current pregnancy. The headache attacks occur two to four times monthly and last 12 to 24 hours. She experiences moderately severe pain, significant nausea, no vomiting, and pronounced photophobia with most of the attacks. Her only medication is prenatal vitamins. Physical examination findings, including vital signs, are normal. What is the most appropriate treatment?

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